Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS

February 12, 2026 updated by: Ethicon, Inc.

A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures

This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany
        • Universitaetsklinikum Hamburg Eppendorf
      • Kiel, Germany
        • Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie
  • Italy
      • Naples, Italy
        • University of Naples
      • Pisa, Italy
        • University Pisa
  • United States
    • Florida
      • Miami, Florida, United States, 33173
        • Baptist Health South Florida
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10029
        • Mt. Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects ≥ 18 years who are undergoing elective/non-emergent gastric or gynecological procedures robotically

Description

Inclusion:

  1. Elect to have a Robotic Bariatric Sleeve Gastrectomy or Robotic Total Hysterectomy where STRATAFIX™ Spiral PDS™ Plus device is used for staple line re-enforcement or vaginal cuff closure, respectively
  2. Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled
  3. Subjects are ≥ 18 years of age

Exclusion:

  1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits
  2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
  3. Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints
  4. Allergic to poly (p-dioxanon), IRGACARE®* MP (triclosan) or D&C Violet No. 2 colorant
  5. Pregnant or lactating female subjects as confirmed prior to the procedure
  6. Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu & Morrow classification or gastric sleeve revision surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stratafix Arm
The single study arm would comprise of two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure).
Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
  1. Robotic Bariatric Sleeve gastrectomy
  2. Robotic Hysterectomy with or without oophorectomy;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects with no bleeding or mild bleeding (defined as success) at the completion of the suturing at the organ layer (vaginal cuff closure or gastric staple line reinforcement using STRATAFIX™ Spiral PDS™ Plus).
Time Frame: Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)
The bleeding grade assessment used for the primary endpoint will be made right after the suturing is completed. Any re-bleeding after the initial assessment (just before the removal of the optics and trocars) from the suture line after this assessment will be considered a failure for the primary performance endpoint.
Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative Assessment of Suture Handling
Time Frame: Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery)
Suture breakage, correction suture used, reinforcement suture used, needle penetration, size, attachment; all rated 1-5
Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery)
Time to Closure (in minutes/seconds)
Time Frame: Intra-op (during suturing of the target tissue, Day of surgery)
The time to closure is defined as time in minutes and seconds between placement of the first suture throw in the target tissue to the completion of closure of that layer. The time in minutes and seconds will be captured as per operating room procedure.
Intra-op (during suturing of the target tissue, Day of surgery)
Overall procedure time (first incision to skin closure)
Time Frame: Intra-op (during the surgery, Day of surgery)
Overall time is calculated as first incision to skin closure
Intra-op (during the surgery, Day of surgery)
Length of stay in hours
Time Frame: Post-Operative up to 48 hrs
Time from admission to discharge
Post-Operative up to 48 hrs
Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion
Time Frame: Intra-Op (during the surgery, Day of surgery)
Blood loss calculated as per the standard of care of each institution
Intra-Op (during the surgery, Day of surgery)
Intra-operative leak test in bariatric procedure as per institutional standard of care, if any
Time Frame: Intra-op (during Surgery; Day of surgery)
Leak test for sleeve gastrectomy patient as per institution standard
Intra-op (during Surgery; Day of surgery)
Post-operative male/female dyspareunia related to sutures (total hysterectomy subjects)
Time Frame: 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
Dyspareunia here is defined as painful sexual intercourse due to the sutures
90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
Incisional site physical assessment:is suture palpable, suture line intact, or tender (all rated yes/no)
Time Frame: 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
Incisional site will be assessed for hysterectomy subjects to see if the suture is palpable suture, tender or intact at the target site
14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
Abnormal vaginal discharge (total hysterectomy subjects)
Time Frame: 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
Hysterectomy patients will be assessed for any abnormal vaginal discharge if any.
14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
C-SATS GEARS score
Time Frame: Intra-op (during the surgery, Day of surgery)
Global Evaluative Assessment of Robotic Skills (GEARS). Its a validated assessment tool for grading overall technical proficiency for robotic surgery. GEARS measures manual dexterity and fluidity of motion and does not define surgical or clinical judgement. The scales are Depth perception, Bimanual dexterity, efficiency, force sensitivity and robotic control.Each scale is scored 1 - 5, which means the total score could range from 5 - 25.
Intra-op (during the surgery, Day of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ethicon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESC_2018_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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